AstraZeneca
Samples Operations Manager, Translational Medicine, Oncology R&D
AstraZeneca, Waltham, Massachusetts, United States, 02254
Samples Operations Manager, Translational Medicine, Oncology R&D(Waltham)At
AstraZeneca , we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.Oncology Translational Medicine GenomicsThe Translational Medicine function exists within Oncology R&D to ensure effective and strategic biomarker studies for oncology project teams. Closely interacting with the pre-clinical Discovery, Early Clinical Development, and Precision Medicine & Biosamples diagnostics functions, Translational Medicine is the single point of accountability for delivery of robust, scientifically-driven biomarkers to all Oncology project teams, providing feasibility assessments, technical validation, centralized biomarker analysis capability for clinical samples, delivery of translational science research and early clinical phase engagement.The Global Genomics team within Translational Medicine function leverages Next Generation Sequencing (NGS) and other advanced technologies to match the right patient to the right drug and support precision oncology approaches for the AZ Oncology pipeline.Major Responsibilities and AccountabilitiesThis position will focus on the following core areas of Sample Operations (e.g., Sample Logistics, Sample Management, HBS Compliance, etc.)Human Biological Sample Compliance Documentation CoordinationFollow established SOPs and working guides to:
Manage HBS end-to-end compliance process for human biological samplesComplete sample compliance documentationCoordinate sample arrival and chain of custody with AstraZeneca biobank and third parties
Management and Coordination of Domestic and International Sample Logistics Management and Coordination:Coordinate shipping and receiving of human biological samples between domestic and international externally sponsored research studies, vendors and AstraZenecaGenerate, manage, track and drive to closure shipments of collaborator samples including international shipping documentation (commercial invoice, EPL, licenses, VAT, logistics provider scheduling and PO generation)Commercially Procured, Collaborator and Clinical Trial Sample Management:Under direction, purchase commercially procured samplesComplete compliance and biobank documentation to ingest samples into biobankTrack samples in LIMSCoordinate internal sample shipments between labs, manage chain of custodySample Management Process Improvements Development:Assist in establishing operational process and procedure to provide excellent and strong operational support to research labsAct as escalation point to manage issues related to specimen and results managementIdentify process gaps in specimen management and make recommendations for continuous improvement with a focus on resource usage and turn-around timeEssential for the roleB.A, B.S. in Biotechnology, Biology or Management, or related degree with 1+ years of sample management and/or sample logistics experience in a pharmaceutical, diagnostics or related research settingExperience with Oncology, Translational Medicine or early stage clinical trialsDemonstrated success in managing human biological samples (FFPE, Frozen Samples)Experienced in quickly building positive and trusting relationshipsStrong team leadership skills, oral and written communication skills with the ability to work with others to achieve objectivesDesirable for the roleExperience with LIMS and/or BiobankingExperience with international sample shipping and/or sample management of academic or commercial HBSAbility to multi-task in a fast-paced environment with changing priorities, comfort with ambiguityA sense of ownership to deliver high quality work in a research settingAbout AstraZeneca in Waltham, MAThe Waltham R&D site focuses on our small-molecule oncology research in North America, and is situated within a biopharma cluster of research institutions, medical centers, pharmaceutical companies and startups. The Boston region is consistently ranked #1 globally for research, investment, talent recruitment and lab space.Our Waltham MA facility creates life-changing medicines for people around the world. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to encourage teamwork and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to crafting a culture of inclusion and collaboration.The Waltham site offers a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, and electric vehicle charging stations, full-service cafeteria and copy center.The campus, also known as the Boston BioHub, is one of the largest and most dynamic life-science research hubs in the region. It is home to more than 800 scientists working in nine different pharmaceutical and biotech companies. The site is also home to the AstraZeneca Incubator, a program that helps emerging companies advance novel and innovative healthcare solutions to meet the needs of patients.
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AstraZeneca , we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.Oncology Translational Medicine GenomicsThe Translational Medicine function exists within Oncology R&D to ensure effective and strategic biomarker studies for oncology project teams. Closely interacting with the pre-clinical Discovery, Early Clinical Development, and Precision Medicine & Biosamples diagnostics functions, Translational Medicine is the single point of accountability for delivery of robust, scientifically-driven biomarkers to all Oncology project teams, providing feasibility assessments, technical validation, centralized biomarker analysis capability for clinical samples, delivery of translational science research and early clinical phase engagement.The Global Genomics team within Translational Medicine function leverages Next Generation Sequencing (NGS) and other advanced technologies to match the right patient to the right drug and support precision oncology approaches for the AZ Oncology pipeline.Major Responsibilities and AccountabilitiesThis position will focus on the following core areas of Sample Operations (e.g., Sample Logistics, Sample Management, HBS Compliance, etc.)Human Biological Sample Compliance Documentation CoordinationFollow established SOPs and working guides to:
Manage HBS end-to-end compliance process for human biological samplesComplete sample compliance documentationCoordinate sample arrival and chain of custody with AstraZeneca biobank and third parties
Management and Coordination of Domestic and International Sample Logistics Management and Coordination:Coordinate shipping and receiving of human biological samples between domestic and international externally sponsored research studies, vendors and AstraZenecaGenerate, manage, track and drive to closure shipments of collaborator samples including international shipping documentation (commercial invoice, EPL, licenses, VAT, logistics provider scheduling and PO generation)Commercially Procured, Collaborator and Clinical Trial Sample Management:Under direction, purchase commercially procured samplesComplete compliance and biobank documentation to ingest samples into biobankTrack samples in LIMSCoordinate internal sample shipments between labs, manage chain of custodySample Management Process Improvements Development:Assist in establishing operational process and procedure to provide excellent and strong operational support to research labsAct as escalation point to manage issues related to specimen and results managementIdentify process gaps in specimen management and make recommendations for continuous improvement with a focus on resource usage and turn-around timeEssential for the roleB.A, B.S. in Biotechnology, Biology or Management, or related degree with 1+ years of sample management and/or sample logistics experience in a pharmaceutical, diagnostics or related research settingExperience with Oncology, Translational Medicine or early stage clinical trialsDemonstrated success in managing human biological samples (FFPE, Frozen Samples)Experienced in quickly building positive and trusting relationshipsStrong team leadership skills, oral and written communication skills with the ability to work with others to achieve objectivesDesirable for the roleExperience with LIMS and/or BiobankingExperience with international sample shipping and/or sample management of academic or commercial HBSAbility to multi-task in a fast-paced environment with changing priorities, comfort with ambiguityA sense of ownership to deliver high quality work in a research settingAbout AstraZeneca in Waltham, MAThe Waltham R&D site focuses on our small-molecule oncology research in North America, and is situated within a biopharma cluster of research institutions, medical centers, pharmaceutical companies and startups. The Boston region is consistently ranked #1 globally for research, investment, talent recruitment and lab space.Our Waltham MA facility creates life-changing medicines for people around the world. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to encourage teamwork and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to crafting a culture of inclusion and collaboration.The Waltham site offers a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, and electric vehicle charging stations, full-service cafeteria and copy center.The campus, also known as the Boston BioHub, is one of the largest and most dynamic life-science research hubs in the region. It is home to more than 800 scientists working in nine different pharmaceutical and biotech companies. The site is also home to the AstraZeneca Incubator, a program that helps emerging companies advance novel and innovative healthcare solutions to meet the needs of patients.
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